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					               MICK® 200-TP Applicator Kit
                                      Catalog # 8810

             Instructions for Use

                                   Date: _________________

                                   Model # 8810

                                   Serial #_______________

                For future references, please note the applicator’s serial number
                                    shown in the box above.

       The applicator’s serial number is stamped into the Magazine Receptor of your
                                  Mick 200-TP Applicator.



        SERVICE YOUR MICK 200-TP APPLICATOR REGULARLY!



                                                      An ISO 13485 Certified Company




                                   521 Homestead Avenue
                            Mount Vernon, New York 10550 USA
              Tel: 914-667-3999 / Fax: 914-665-8834 / Toll-Free: 877-597-MRNI
            E-mail: sales@micknuclear.com / Website: www.micknuclear.com



Form #: 405-05; Rev. F; 03/30/07
                                                                                                               Table of Contents
                                                                                                                             General Information
MICK 200-TP APPLICATOR
TABLE OF CONTENTS....................................................................................................................       Page 1
             GENERAL INFORMATION..…………………………………..........……................                                                                 Page 1

MICK 200-TP APPLICATOR KIT......................................................................................................            Page 2
               CONTENTS..........................................................................................................           Page 2

MICK 200-TP APPLICATOR ............................................................................................................         Page 3
               PARTS DESCRIPTION …………………………………..................................…...                                                        Page 3

MICK 200-TP APPLICATOR (Continued).......................................................................................                   Page 4
              SCHEMATIC ILLUSTRATION ……………...........................…….........................                                            Page 4

IMPORTANT APPLICATOR DETAILS ………….....................................................……..........……                                        Page 5
             NEEDLE RECEPTOR …………………………………………………........………...                                                                              Page 5
             MAGAZINE RECEPTOR ……………………………………………........……….….                                                                              Page 5

MICK MAGAZINE (I-125 / Pd-103)……………………………….................……………….........……                                                                Page 6
             TECHNICAL DESCRIPTION ………………………………………………….......…                                                                              Page 6
             INSTRUCTIONS FOR USE ………………………………………………….......…..                                                                             Page 6
             MANUAL SEED LOADING …………………………………………………........…..                                                                             Page 6

MICK MAGAZINES — CONTINUED................................................................................................                  Page 7
             NEW DESIGN NOTICE........................................................................................                      Page 7
             RECOMMENDED SERVICE SCHEDULE...........................................................                                        Page 7

MICK MAGAZINES...........................................................................................................................   Page 8
             VARIOUS TYPES ………………………………………………………...................                                                                         Page 8
             STERILIZATION PROCEDURES ……………………………………………….....                                                                               Page 8
             RADIATION SAFETY ……………………………………………………………......                                                                                 Page 8
             WASTE DISPOSAL ……………………………………………………………….....                                                                                   Page 8

STERILIZATION PROCEDURES ...................................................................................................                Page 9
              VALIDATED …………………........………………….……................................…..                                                        Page 9

CLEANING PROCEDURES.............................................................................................................            Page 10
            RECOMMENDED …………………………………….........………….....................                                                                    Page 10

MICK “RIPPLE-HUB” NEEDLE......................................................................................................              Page 11
              NEEDLE SPECIFICATIONS ………………….……........……............................                                                        Page 11

MICK “RIPPLE-HUB” NEEDLE (Continued).................................................................................                       Page 12
              DETAILED ILLUSTRATION ………………..........……………............................                                                       Page 12

MORGENSTERN STABILIZATION NEEDLES ………….……………………........…..……………..                                                                           Page 13

PRECAUTIONS…………………………………………………………………………………………….                                                                                             Page 14
            RADIATION SAFETY…………………………………………………………………                                                                                       Page 14
            RADIATION PROTECTION………………………………………………………….                                                                                     Page 14

IMPLANT SEQUENCE.....................................................................................................................       Page 151& 16
             RECOMMENDED …………………………………………….........……….............                                                                         Page 15 & 16

USEFUL TIPS ………………………………………………………………………………..........…….....                                                                                 Page 17
             PREPARATIONS ………………………………………………………………..........                                                                                Page 17
             CAUTION.............................................................................................................           Page 17
             SEED ACCOUNTABILITY ……………………………………………………...........                                                                            Page 17
             POST SURGERY CHECKS ……………………………………………………........                                                                               Page 17
             BALL-TIPPED PROTECTIVE SHEATH...............................................................                                   Page 17

USEFUL TIPS (CONTINUED)……………………………………………………………………………..                                                                                      Page 18
              THINGS TO BE AWARE OF………………………………………………………….                                                                                  Page 18

RETURN AUTHORIZATION / RETURNING “HOT” APPLICATORS / WARRANTY / DISCLAIMER Page 19


                                                                     1
                                          Mick® 200-TP Applicator Kit
                                                                          Contents




  Kit Consists of:
  1.    1 EA CAT. # 8810-I            MICK 200-TP APPLICATOR INSTRUMENT

  2.    8 EA   CAT. # 7609            SEED MAGAZINES - REUSABLE (I-125 or Pd-103)

* 3.    1 EA   CAT. # MTP-17/18-20C   “AUTHENTIC” MICK TP NEEDLES, DISPOSABLE

  4.    1 EA   CAT. # 7509            LOADING V-BLOCK

  5.    1 EA    CAT. # 7901           SEED STERILIZER & CARRIER

  6.    1 EA   CAT. # 8816            DIDDLER

  7.    1 EA   CAT. # 7613            REVERSE ACTION TWEEZER

  8.    1 EA   CAT. # 7702            LOOP WIRE

  9.    1 EA   CAT. # 7610            STAINLESS STEEL RULER (15CM)

  10.   4 EA   CAT. # 7609-E          E-RINGS - (SPARES)

  11.   1 EA   CAT. # 7311-C          ST. STEEL ALLENWRENCH

  12.   1 EA   CAT. # 8113-PIP        PRACTICE PHANTOM + 100 DUMMY SEEDS

  13.   1 EA   CAT. # 0506            STERILIZATION / STORAGE CASSETTE

  14.   1 EA                          INSTRUCTION MANUAL


  *NOTE: 1 CARTON OF MICK “RIPPLE-HUB” TP NEEDLES ARE PROVIDED WITH THE KIT,
                           CHOICE OF 17 OR 18 GAUGE.


                                      2
                                                                                  Mick 200-TP Applicator
                                                                                                           Parts Description
Mick 200-TP Applicator - Cat: # 8810-I


                                                                                                                    14
                                                                              9
                                                                                                 12
                                   7
                                                                5
                                        2                                                                           13

                       1                                                                              11
                                                                                            10
      3                                                                   8
                                             4                 6




 Template Ring (1):
 The Template Ring (1) which is connected to the Black Cone (10) by means of two parallel
 rods, serves as a foot (reference point) when placed against the transperineal template. It is
                                                                                                      Parts
 important to keep the Template Ring moving freely on the Main Barrel. If motion is hampered,
 turn slotted screw located on top of the Black Cone (10) 1/2 turn counter clock wise. If problem
                                                                                                      Description
 remains, return the Applicator to Mick Radio-Nuclear Instruments, Inc. for repair.

                                                                                                      1. Template Ring
 Needle Release Button (2):                                                                           2. Needle Release Button
 The needle release button (2) is under spring tension to ensure capture of the inserted Mick         3. Mick TP Needle
 “Ripple-Hub” Needle (3). When blocked by residual blood and tissue, the release button may
 stick and needles may not hold. It is imperative to keep this part of the instrument clean and       4. Needle Receptor
 free of blood. Use lubrication to ascertain free movement of the needle release button.              5. Magazine Receptor
 Continuously rinse the Applicator in sterile water during surgery.
                                                                                                      6. Serial Number
                                                                                                      7. Seed Cartridge
 Magazine Receptor (5):
                                                                                                      8. Template Ring
 Upon removal of the Seed Cartridge (7), the magazine receptor (5) must be kept clean and
 free of blood. When blood appears in the magazine receptor, rinse the entire front portion                Stabilizer
 of the applicator in STERILE WATER to free up biological matter.                                     9. Finger Ring
                                                                                                      10. Black Cone
 Pushwire Rod Assembly (13):                                                                          11. Adjustment Screw
 The pushwire rod assembly, (13) should be removed upon completion of an implant for
                                                                                                      12. Main Barrel
 cleaning. To do so, turn the knurled main barrel end-cap (13) counter clock-wise until the entire
 assembly can be pulled out of the main barrel. Clean the inner part of the barrel together with      13. End Cap &
 the pushwire rod assembly by means of ULTRASONIC CLEANERS. Remove after 15
                                                                                                           Pushwire Rod
 minutes and rinse with warm water. After steam sterilization, instruments tend to be dry and
 sterile water will ensure for smooth motion. Carefully reinsert stylet / pushwire rod assembly            Assembly
 back into barrel and turn end-cap clock-wise until it is tight.
                                                                                                      14. Pushwire Knob
 ♦   Stylet must be straight and move freely through the applicator and needle.
 ♦   Defective Applicators must not be used for surgery; return Applicator to Mick Radio-
     Nuclear Instruments, Inc. for service or repair.


                                                                3
                                                                  Mick 200-TP Applicator

                                      Schematic Illustration, Major Components & Moving Parts

   The Mick 200-TPV Applicator consists of 6 major components and 4 moving parts:
     Major Components:       Needle Receptor / Magazine Receptor / Main Barrel / Black Cone /
                               Template Ring / Pushwire Rod Assembly.
                                 (Needles and Magazines are excluded)

     Moving Parts:                    Black Cone / Pushwire Rod Assembly (Stylet) /
                                  Template Ring Rod Assembly / Needle Release Button.

     Please note:    The Needle Receptor is not shown in detail in this diagram due to its intricacies.

Schematic Illustration
of Mick 200-TP
Applicator


                            Template Ring is connected to the
                           Black Cone. Both components move
                           simultaneously along the Main Barrel.


                                  Main Barrel End Cap
                             Holds Pushwire Rod Assembly in
                               place, (See bottom page 3)

                                 Pushwire Rod Assembly
                              Serves to manually insert seeds.
                               (Moves stylet through needle)


                      Pushwire Rod Assembly (All one unit - Do not disassemble)
              Unscrew from Applicator for cleaning and sterilization
  Stylet (must remain straight)            Pushwire Rod Guide                                  Pushwire Knob




                                                         Pushwire Rod             Pushwire Rod End Cap



                                      Items Not To Be Tampered With:
    ♦   Template Ring Rod Assembly must not be removed or disassembled.
    ♦   Needle Receptor must not be disassembled.
                                    Items to be disassembled for cleaning:
    ♦   Pushwire Rod Assembly (The pushwire rod assembly consists of four parts; stylet, pushwire rod guide,
        pushwire rod and pushwire knob.) If the stylet is bent or kinked, return instrument for repair.
        For best cleaning results, unscrew the pushwire rod assembly from the applicator and clean
        as recommended on page 10.

                                                     4
                                                               Important Applicator Details
                                                                                             Needle Receptor
                                                                                      Mick Magazine Receptor
  Needle Receptor & Magazine Receptor                                          Needle Receptor:
                                                                The needle receptor, sometimes referred to as the
                                                                “needle chuck”, is most likely to cause problems
 Shielded / Disposable             Magazine Receptor            when unattended. Blood can accumulate inside
       Magazine                       (Shielded)                causing the needle grabbing mechanism to stick
                                                                which prevents the needle from properly seating
                                                                within the applicator. Consequently, seeds may
                                                                jam! Continuous rinsing in sterile water has proven
  Needle Release                                                to be very effective in keeping the Applicator and
      Button                                                    its moving components in optimal operating condi-
                                                                tions.

                                                                Caution:
                                                                Ascertain that needles are “firmly” held captive
                                                                when inserted into the Applicator’s needle recep-
                                                                tor! Perform pull-test. Ascertain that the yellow or
                                                                blue sleeve of the needle completely disap-
                                                                pears within the needle receptor. If the colored
                     Needle Receptor                            needle sleeve is protruding and visible, a seed
                                                                jam is very likely to occur.


           Mick Magazine Receptor                               The Magazine Receptor, shown to the left and be-
                                                                low, provides a well for the insertion of Mick Maga-
                                                                zine. The magazine’s design allows for insertion of
                 Mick Magazine Well                             magazines with capacities of up to a maximum of
                                                                20 seeds. The Magazine Receptor fully encircles
                                                                an inserted portion of the shielded Mick Magazine
                                                                thus providing excellent all-around radiation shield-
                                                                ing.
                                                                The magazine receptor accepts Mick magazines by
                                                                conveniently clicking them into the Magazine Well.
                                                                There is a lock-out to ensure the magazine can be
       Applicator Serial                                        inserted with “seeds facing to the right” only! (See
      Number (Engraved)                                         page 6.)

Please note:                                                                 Drainage Slots (4)
The Magazine receptor must be kept free of blood at
all times. It is therefore highly recommended that
flushing and rinsing by means of sterile water under
pressure, is carried out continuously during the implant
procedure.
Ignoring the recommendation may result in the IN-
ABILIITY to seat the Mick Magazine correctly. If the
Mick Magazine is seated incorrectly, seeds may not be
ejected from the magazine thus causing the magazine
to jam.
  Use Ultrasonic Cleaners for best cleaning results!            Additionally, the bottom of the Magazine Receptor
                   (See page 10.)                               is provided with 4 drainage slots for ease of rinsing
                                                                and cleaning.




                                                           5
                                                                                            Mick Magazines
                             Technical Description / Instructions for Use / Manual Seed Loading

      ♦    Mick Magazines are designed for use with I-125 and Pd-103 seeds.
      ♦    All Mick Magazines are IDENTICAL in PRINCIPLE.
      ♦    Handling, precautions and seed loading procedures are identical for all magazines.

 Shielded Disposable Mick Magazine                            Insertion of Magazine into the Mick Applicator
                                                                                           Always Insert Magazine Seeds
   E-Ring                                Warning!                                               Facing to the Right!
 (Snap-Ring)                           Do Not Handle
                                       Magazine by the                                         MICK MAGAZINES ARE
                                       Spring-Loaded                                        DESIGNED TO SEAT INTO THE
                                          Plunger                                           MICK APPLICATOR BY SIMPLY
                                                                                               PUSHING IT INTO THE
                                                                                            MAGAZINE RECEPTOR WITH A
   Threaded                               Round                                                NOTICEABLE “CLICK”.
Magazine Head                            Magazine                 WARNING:
 for storage in                            Head
Seed Sterilizer                       Brass –Coated       MICK MAGAZINES ARE NOT DESIGNED TO SCREW INTO
  (see below)                          (Color Silver)     OR OUT OF THE APPLICATOR. THE OUTSIDE THREADS
                                                          ARE TO BE USED TO AFFIX MAGAZINES TO THE V-
                                                          BLOCK FOR SEED LOADING AND TO THE SEED STERI-
                                                          LIZER BLOCK FOR STERILIZATION. (See below.)
                                     Fully loaded Mick
                                         Cartridge.            DO NOT LOAD MICK MAGAZINES ABOVE THE
Seed Cartridge                           Seeds are                  CAPACITY OF SEEDS SPECIFIED!
    (PES)                             stacked parallel        OVERLOADING WILL CAUSE SEEDS TO JAM!
 (Color White)                         on top of each
                                            other.            ♦    Do not handle the magazine by the protruding
                                                                   spring-loaded plunger.
                                                              ♦    Do not over tighten the round magazine head.
Loaded Seed Magazines stored in Seed                          ♦    Do not let seeds drop into the slot of the seed
Sterilizer Block                                                   cartridge.
                                                              ♦    Do not use force on seeds; handle seeds gently!
Radiation Protection:                                         ♦    Initiate radiation surveys on all components upon
Readings taken at the handle                                       completion of seed implants.
of the Seed Sterilizer Block                                  ♦    Use appropriate radiation protection and precau-
(outside the housing) contain-                                     tions when handling radioactive materials.
ing 150 each I-125 Seeds with
a total activity of 53.1mCi                                       ♦    ASCERTAIN THAT ALL CARTRIDGES ARE
measured 0.02mR/h.                                                         “EMPTY” PRIOR TO DISPOSAL.

              Manual Seed Loading                             • Place 10, 15 or 20 Seeds into the well of
                                                                  the Seed Loading V-Block.
                                                              • Hold the Reverse Action Tweezer as
    Magazine Storage (5)         Seed Well      Hold              shown with the 3 marks on “top”! (Grooved
                                              tweezer             tweezer tip must be up).
                                             with the 3       •   Pick up a seed as close to the center as
                                               marks              possible.
                                             (grooves)        •   Align the seed with the slot in the seed
                                               facing             cartridge.
                                              upwards         •   Feed the seed down into the slot until it is
                                             to grab a            seated on the bottom of the cartridge or on
                                                seed.             top of the previous seed.                      Empty Cartridge /
                                                              •   Release the seed and pull tweezer out          Loaded Cartridge /
                                                                  straight.                                        Disassembled
                                                              •   Pick up the next seed and continue loading         Cartridge
                                                                  as above.

                                                                  CAUTION: DO NOT DROP SEEDS INTO CARTRIDGES AND
                                                                     ALWAYS USE PROPER RADIATION PROTECTION.

                                                          6
                                                                       Mick Magazines Continued
                                                                                               New Design Notice
                                                                                    Recommended Service Schedule
  Plunger Up / Plunger Down
                                                    Be aware of remaining seed in cartridge!

                                                                                      Recently the design of the Dis-
                                                                                      posable Mick cartridge for the
                                                                                      Mick Applicator was changed for
                                                                                      smoother operation and produc-
                                                                                      tion safety.

                                                                                      With the new design it is now
                                                                                      possible, that the last seed is
                                                                                      not directly visible under certain
                                                                                      viewing angles, although there
                                                                                      is still one in the cartridge.
                                                                                      When you look under 90° to the
                                        Seed visible when    Seed invisible when      cartridge axis you can’t see the
                                        looking down into     looking up into the
                                                                                      last seed anymore, only the
                                          the cartridge.           cartridge.
                                                                                      lifted plunger on top indicates
Left:  1 seed left in cartridge;                                                      there is still a seed inside.
        plunger is sticking up.
Right: No seed left in cartridge;
       plunger down.

              Check for remaining seeds by inspecting the plunger first, then look for a last seed
                   under an appropriate viewing angle, if unsure use a radiation detector.
                Before disposing empty cartridges always check with a contamination monitor,
                                  that they are free from any contamination.

                                       CONDUCT RADIATION SURVEY!

                             RECOMMENDED SERVICE SCHEDULE FOR
                       MICK APPLICATORS AND MICK REUSABLE MAGAZINES
              The Mick 200 –TP Applicator, Mick 200-TPV Applicator and Mick Reusable Magazines are
                     designed for reuse and are to be cleaned and sterilized prior to each use.
                                    These products contain no user serviceable components.
                                        Any and all repairs must be performed by
                                    MRNI’s qualified service personnel at MRNI’s facility.
                    The life expectancy of these products is based on PERIODIC INSPECTION and
                                             REPAIR performed by MRNI.
             These products can last indefinitely when they are inspected and repaired as needed
                                    and at the recommended frequency.
MRNI recommends the following:
                           Product                                           Service Frequency
                  Mick 200-TP Applicator                                      Every 50 Implants
                 Mick 200-TPV Applicator                                      Every 50 Implants
                Mick Reusable Magazines                                       Every 50 Implants

                 IMPORTANT: WHEN A MALFUNCTION OCCURS, IMMEDIATELY CONTACT
                     MRNI TO OBTAIN A RETURN AUTHORIZATION NUMBER AND
                          INSTRUCTIONS TO SEND PRODUCT IN FOR REPAIR!

                                                               7
                                                                                 Mick Magazines
                   Various Types, Sterilization Procedures, Radiation Safety, Waste Disposal

       ♦ Mick Magazines can be “AUTOCLAVED”. (Autoclave disposable magazines only once!)
       ♦ Seed manufacturers may provide Mick Magazines pre-loaded, packaged and shipped
         sterile.
       ♦ Mick Magazines are compatible with the Mick 200-TP Applicator.
       ♦ Disposable Mick Magazines are for “ONE-TIME” Use Only!

                            AVAILABLE TYPE MICK MAGAZINES

                                           CAPACITY
      TYPE               CAT. #                                   MATERIAL                STERILIZATION
                                         (# OF SEEDS)
A) REUSABLE 20                                  20
     SHIELDED             0410                                       ST. STEEL             AUTOCLAVE
B) REUSABALE 10                                 10
     SHIELDED             7609                                       ST.STEEL              AUTOCLAVE
C) DISPOSABLE 15                                15                    PES
    UNSHIELDED            7609-D                              (POLYETHERSULFONE)           AUTOCLAVE
D) DISPOSABLE 15
                         0216-DS                15                    PES,
                                                                                           AUTOCLAVE
      SHIELDED                                                    PLATED BRASS


                                                             STERILIZATION PROCEDURES

                                                          STERILIZATION:             AUTOCLAVE:
                                                          Temperature:               250°F / 121°C
                                                          Pressure:                  15 psig
                                                          Sterilization Time:        30 Minutes

                                                          STERILIZATION:             FLASH CYCLE:
                                                          Temperature:               270° F / 132°C
                                                          Pressure:                  27 psig
                                                          Sterilization Time:        10 Minutes
           A         B      C       D


                          RADIATION SAFETY / WASTE DISPOSAL
       ♦   Check for residual seeds in all areas around the surgical site.
       ♦   Store residual seeds in appropriately shielded containers.
       ♦   Conduct a radiation survey on the Mick Applicator.
       ♦   Conduct a radiation survey on all used needles.
       ♦   Conduct a radiation survey on all used disposable magazines (cartridges).
       ♦   Conduct a radiation survey on accessory tables.
       ♦   Conduct a radiation survey on drapes and disposable items prior to disposal!
       ♦   Document number of seeds implanted.
       ♦   Document number of seeds unused.
       ♦   DO NOT EXIT THE OPERATING SUITE WITHOUT A THOROUGH RADIATION SURVEY
           EXECUTED BY A RADIATION SAFETY OFFICER.
       ♦   FOLLOW HOSPITAL RULES AND PROCEDURES FOR THE DISPOSAL OF SHARPS AND
           OTHER USED HAZARDOUS MATERIALS.


                                                      8
                                                            Sterilization Procedure

                                                                                            Validated
           Recommended Sterilization Procedures for
            MICK 200-TP Applicator and Accessories
ITEMS THAT CAN BE AUTOCLAVED OR GAS (EtO) STERILIZED:
The Mick 200-TP Applicator and Accessories such as Reusable and Disposable Magazines,
Loading V-Block, Reverse Action Tweezer, Stainless Steel Ruler, Loop Wire, Allen wrench,
Seed Sterilizer and Insert, Reusable Transperineal Templates, Diddler and Sterilization Cassette
CAN BE AUTOCLAVED or GAS (ETO) STERILIZED.

ITEMS THAT CANNOT BE AUTOCLAVED OR GAS (EtO) STERILIZED:
All plastic and packaging material must be removed prior to steam sterilization.
Practice Phantoms and Sterile / Disposable Mick TP Needles CANNOT be sterilized.


            *VALIDATED STERILIZATION PARAMETERS

   Remove Pushwire Rod Assembly from Applicator for Cleaning
   and Sterilization and place these and other Accessories being
          sterilized into the Sterilization Cassette or Tray.


A) AUTOCLAVE:                  Gravity Displacement or Pre-vacuum
     TEMPERATURE:                      250º F / 121° C  PRESSURE: 15 psig
     STERILIZATION TIME:               30 MINUTES (In Stainless Steel Tray)
                                       45 MINUTES (In Sterilization Cassette)



B) FLASH CYCLE:                Gravity Displacement or Pre-vacuum
     TEMPERATURE:                       270º F / 132º C    PRESSURE: 27 psig
     STERILIZATION TIME:                3 MINUTES (In Sterilization Cassette or Stainless
                                        Steel Tray - MICK 200-TP APPLICATOR ONLY)



C) GAS (ETO) STERILIZATION:
     TEMPERATURE:                      135º F / 57º C  PRESSURE: 8.5 psig
     STERILIZATION TIME:               1 HOUR & 45 MINUTES
     AERATION TIME:                    12 HOURS


       * The use of sterilization protocols other than the above
                  are the responsibility of the user.
                                               9
                                                           Cleaning Procedures
                                                                          Recommended
                  Recommended Cleaning Procedures
                  Mick 200-TP Applicator & Accessories
                                      Catalog # 8810
                           Ultrasonic Cleaners:
   For Best Cleaning Results Use Ultrasonic Cleaning Devices

ULTRASONIC CLEANING REACHES INTO SMALL AND INACCESSIBLE CREVICES THROUGH
HIGH FREQUENCY VIBRATIONS TO LOOSEN RESIDUAL BLOOD AND TISSUE. CONTINUOUS
RINSING DURING SURGERY AND IMMEDIATELY THEREAFTER, WILL PREVENT BLOOD
FROM CLOTTING WITHIN THE APPLICATOR.



                    Recommended Ultrasonic Cleaner
                     Catalog # 7908-7 / Capacity: 2.5 Gallons
                         Tank Size: 19.5” x 5.25” x 6” (LWH)



The Mick 200-TP Applicator with its many “moveable parts” (see pages 3 and 4) requires
thorough cleansing as blood frequently finds its way through the needle and into the needle
receptor. The needle receptor containing the spring-loaded finger, which latches onto the
needle, must remain free of blood or tissue. If left without maintenance, the needle may not
hold properly (See page 5).

      Prior to and most importantly during the surgical procedure, it is highly
  recommended to continuously rinse the applicator and its moving parts in sterile
                                      water.

           Recommended Cleaning and Disinfectant Agents
               Ecolab: Asepti-Solid System (www-st.ecolab.com)
                             Steris                (www.steris.com)
                  Or, use those recommended by the hospital.



      NOTE: COMMONLY USED SURGICAL INSTRUMENT CLEANERS AND
  DETERGENTS ARE NOT DESTRUCTIVE AND DO NOT AFFECT OR COMPROMISE
                  THE INTEGRITY OF THE APPLICATOR.

                                            10
                                                                  Mick TP “Ripple-Hub” Needle
                                                                                       Needle Specifications

               Sterile • Disposable • Siliconized • Calibrated • Economical

 Cat. # MTP-1820-C                                                                       Cat. # MTP-1720-C




                                           18 Gauge                   17 Gauge


                                  Brachytherapy Mick TP “Ripple-Hub” Needle
     Catalog #              Description       Hub Color                        Quantity
    MTP 1720-C           17 Gauge x 20cm      Blue Hub         25 needles per box: 3 packs of 5 needles
                                                                     and 10 single needle packs.
    MTP 1820-C           18 Gauge x 20cm     Yellow Hub        25 needles per box: 3 packs of 5 needles
                                                                     and 10 single needle packs.

The Mick TP “Ripple-Hub” Needles are designed and
manufactured in accordance to Mick tolerances and
specifications. Emphasis and special attention are given to
the needle’s compatibility with Mick 200-TP and 200-TPV
Applicators. The fit of the needle within the applicator’s
needle receptor is carefully controlled. More importantly, the
entrance hole to the needle is funneled for smooth transfer
of seeds from magazines into the needles. The calibration
allows setting needles to equal depths (if so desired) without
the necessity of rulers. The bands are 5mm long with 5mm
clear areas in between.



INSTRUCTION FOR USE:
To insert the needle, it is imperative to apply pressure to the needle hub             DISCLAIMER:
only.
STERILITY:                                                                            Mick Radio-Nuclear
“AUTHENTIC” Mick TP Needles are packaged sterile in cartons of 25                      Instruments, Inc.
needles each. Each carton contains 3 pouches @ 5 needles each and                   voids all liabilities and
10 pouches @ 1 needle each.
                                                                                  warranties when Mick 200-
WASTE DISPOSAL:                                                                      TP and Mick 200-TPV
Dispose of used needles in accordance with hospital “hazardous waste”
                                                                                  Applicators are used with
management procedures.
                                                                                  Disposable Needles, Seed
CAUTION:                                                                         Magazines or Products other
Do not AUTOCLAVE the Mick Applicator with a disposable needle                    than those manufactured or
inserted . The needle’s plastic hub will melt inside the needle chuck              authorized by MRNI, Inc.
which will render your instrument defective and unusable.

                                                                 11
                                                        Mick TP “Ripple-Hub” Needle
                                                                                        Detailed Illustration
                          Ripple-Hub
                    with Orientation Groove

       Needle Sleeve - Funneled




                                                                                          10mm Echogenic
                                                                                          Canula Tip




                                                                                  Trocar Point

Description:
The Mick TP Ripple-Hub Needle is available in both 17 and 18 gauge. The stainless steel obturator fits snugly
into the needle cannula to add rigidity to the needle. When inserted correctly, the needle hub rests against the
needle sleeve and the trocar point tip protrudes from the cannula. When inserted incorrectly, the trocar point
tip of the obturator will slide back into the cannula and remains invisible. (SEE PROPER HANDLING BELOW)



NEEDLE INSERTION

IMPLANT THE NEEDLE WITH PRESSURE
TO THE HUB, NOT TO THE SLEEVE OR SHEATH!


NEEDLE DISPOSAL (SHARPS)
Take care to prevent injuries when using needles, scalpels, and other sharp instruments or devices; when
handling sharp instruments or devices; when handling sharp instruments after procedures; when cleaning
used instruments; and when disposing of used needles. Never recap used needles or otherwise manipulate
them using both hands, or use any other technique that involves directing the point of the needle toward any
part of the body; rather, use either a one-handed “scoop” technique or a mechanical device designed for
holding the needle sheath. Do not remove used needles from disposable syringes by hand and do not bend,
break or otherwise manipulate used needles by hand. Place used disposable syringes and needles, scalpel
blades, and other sharp items in appropriate puncture-resistant containers, which are located as close as
practical to the area in which the items are used, and place reusable syringes and needles in a puncture-
resistance container for transport to the reprocessing area.



MATERIALS USED:
Mick TP Ripple-Hub Needles are made of the finest quality stainless steel where as the hubs and the sleeves
are made of plastic materials. DO NOT AUTOCLAVE DISPOSABLE NEEDLES!


                                                      12
                  Morgenstern-Prostate Stabilization Needle




           Distributed By:

Mick Radio-Nuclear Instruments, Inc.
         521 Homestead Avenue
        Mount Vernon, NY 10550

            Tel: 914-667-3999
          Prostate Stabilizing Needles Can be Autoclaved!
           Fax: 914-665-98834

      E-mail: sales@micknuclear.com



                                      13
                                                                                             Precautions
                                                                                               Radiation Safety
                                                                                            Radiation Protection
  Radiation Safety:
  Personal Radiation Monitoring:
  The use of the Mick Applicators and accessories entails solid radioactive nuclides such as I-125, Pd-103
  or Au-198. As with any radioactive materials, the principles of RADIATION PROTECTION; TIME,
  DISTANCE and SHIELDING should be followed. Radioactive materials should not be handled without the
  necessary personal monitoring devices such as DIRECT READING POCKET DOSIMETERS, FILM and
  RING BADGES. Do not underestimate the radiation exposure from low-energy radionuclides. Treat
  radiation with respect and follow the ALARA principle; keep the exposure:

                                  “AS LOW AS REASONABLY ACHIEVABLE”!
  Never touch or pick-up radioactive seeds with your fingers; use reverse action tweezers provided by
  MRNI.

  To check for residual seeds in needles or areas close to the implant, RADIATION SURVEY METERS are
  required. (Devices as listed above are available through this company - see bottom of this page)

  Radiation Protection:
  Radioactive materials should not be handled without proper SHIELDING. The loading of seeds into
  cartridges should be done behind a protective (Pb) L-SHIELD. Wearing lead-lined rubber gloves
  significantly reduces exposure to fingers and hands. When implanting I-125 seeds, it is recommended that
  a THYROID SHIELD is worn. Implants done under FLUOROSCOPY, require the use of LEAD APRONS.

  INDIVIDUALS UNFAMILIAR WITH RADIATION SAFETY PROCEDURES AND PERTINENT
  REGULATIONS SHOULD CONSULT WITH       RADIATION SAFETY PERSONNEL PRIOR TO
  UNDERTAKING AN IMPLANT WITH RADIOACTIVE NUCLIDES. IT IS IMPERATIVE THAT ALL
  NECESSARY RADIATION PRECAUTIONS ARE IN PLACE. PERSONNEL, PATIENTS AND PATIENT’S
  FAMILIES MUST BE GIVEN THE PROPER INSTRUCTIONS BY THE PHYSICIAN OR INSTITUTION
  PRIOR TO PATIENT’S RELEASE .

                  A number of Guidelines are available through the National Council of Radiation
                             Protection and Measurements , (www.ncrponline.org.)



                Radiation Alert                        The INSPECTOR is a small handheld microprocessor based
                INSPECTOR                              instrument which offers excellent sensitivity to low levels of
  The Ideal “Low-Energy” Seed Finder                   alpha, beta, gamma and x-rays. The digital readout is
                                                       displayed with a red count light and audible beep, providing
                                                       instant indications of the radiation level. Other benefits
                                                       include an adjustable timer and external calibration controls.

                                                       Specifications:
                                                       Detector:
                                                       Halogen-quenched
                                                       uncompensated GM tube
                                                       with thin mica window,
                                                       1.4-2.0mg/cm²     area
                                                       density.
                                                       Effective diameter of window: 45mm (1.75 in.)
                                                       Smallest detectible level for I-125 is 0.02µCi at contact.
Size: 150 x 80 x 30 mm (5.9 x 3.3 x 1.2 in.)
Includes: CE certification, 1 year limited warranty,        Please call Mick Radio-Nuclear Instruments, Inc.
padded vinyl carrying case with belt loop.
                                                           for more detailed information on the INSPECTOR!

                                                           14
                                                                                               Implant Sequence
                                                                                                                  Recommended
Seed Implant Sequence with the Mick 200-TP Applicator:
Please note:
The seed implant sequence may vary depending on the user’s preferences, previous experience and training.
Many physicians have their own ways and techniques of using the Mick Applicator. It Is highly advisable for
new users to attend training sessions or to attend “live demonstrations” and to be proctored by experienced
physicians during the first few prostate seed implants. The descriptions and recommendations as offered
herein are technical only. Clinical aspects of the procedures are the sole responsibility of the user.

Before getting started:
       ♦   Check for the Mick 200-TP Applicator to be in perfect operating condition prior to use.
       ♦   Check for the availability of seeds and back-up instrumentation for use in the OR.
       ♦   Check for availability of Mick “Ripple-Hub” Needles.
       ♦   Check for type of isotope prescribed by the physician; Pd-103 or I-125 or others.
       ♦   Check labeling on the Seed Sterilizer for prescribed isotope, activity and name of patient.
       ♦   Check for the availability of radiation survey equipment.

Recommended Implant Sequence:
 1.        Attach the Mick 200-TP Applicator to the implanted Mick Ripple-Hub Needle.
            Hold the needle with fingers at the template while attaching the Mick Applicator. Ensure that the needle is attached
           firmly. Conduct a pull test! Pull lightly on applicator while still holding the needle at the template. If not fully engaged,
           the needle will slip back out of the needle receptor.
 2.        Advance Template Ring forward until flush with Transperineal Template.
           Hold the Mick 200-TP Applicator steady while advancing the Template Ring. Do not displace the implanted needle.

 3.        Retract the Pushwire Rod (stylet) completely.
           Pull stylet out as far as possible while holding the Mick Applicator steady against the template.

 4.        Insert loaded Seed Magazine into the Mick 200-TP Applicator.
           Note the direction for inserting the cartridge; insert cartridge into the well of the magazine receptor—
           seeds must face to the right. (See insert page 6.) Magazine is properly seated when a noticeable click is heard.

 5.        Retract Needle by “1” click. (1 click = 5 mm)
           While steadying the applicator, retract the needle by 1 click (5mm). This creates a channel and space for the
           placement of the first seed. Hold the applicator steady against the Template while retracting the needle.

 6.        Drop Seed # 1. Advance the Pushwire Rod (stylet) as far forward as possible.
           CAUTION: PUSH THE STYLET FORWARD CAUTIOUSLY — DO NOT PUSH FURTHER THAN TO STOP;
           IF PUSHED TOO HARD - THE NEEDLE WILL BE DISPLACED DISTALLY.

 7.        Retract the Mick Ripple Hub Needle by the desired distance using the “2 click” method.
           2 clicks = 1cm. Caution: RETRACT THE NEEDLE PRIOR TO RETRACTING THE PUSHWIRE ROD (stylet).
           This sequence helps to separate the seed from the needle and from migrating proximally.

 8.        Pull the Pushwire Rod (stylet) back out of the Mick Applicator as far as possible.
           When the stylet is pulled past the magazine, a new seed automatically drops into place.

 9.        Drop seed # 2. Advance the Pushwire Rod as far as possible. (Repeat as above)
           When retracting the stylet, watch for the magazine plunger to descend - listen to the click.
           Caution: If the plunger does not drop - the magazine may be empty or has jammed. In the unlikely event
           of a jam, replace magazine with a new one. DO NOT USE FORCE TO REMOVE THE MAGAZINE. Unscrew the
           magazine head a couple of turns counter clock wise to release the tension on the seeds. Then try to remove the
           magazine. Always keep track of the number of seeds implanted.

 10.       Once the number of seeds per needle are deposited, pull the applicator with the needle
           out of the template. Then disconnect the needle from the applicator by pressing the needle release
           button (see page 5).



                                                                  15
                                                   Implant Sequence - (Continued)
                                                                                               Recommended

Useful Tips During the Implant Procedure:
When Loading the Magazine into the Applicator, ensure the Magazine sets into the Applicator properly, loading
with a noticeable “Click”.

Ensure the needle is properly connected to the Applicator. The needle should “CLICK” into the Needle Receptor
and should not disconnect unless the Needle Release Button is depressed.

During implantation, ensure the seed is completely advanced through the needle. Do not advance the seed par-
tially out of the cartridge and retract the Push-Wire Rod. This may cause the seeds to drop unevenly and seeds
may become jammed in the cartridge.

When loading Mick Magazines, visually check that the seeds are loaded straight and parallel in the cartridge. If
the seeds are placed askew in the cartridge, it may cause jamming during the implant procedure.

After an implant procedure, it is strongly recommended a physical seed inventory be performed to account for all
seeds.

Dislodging Jammed Seeds:
If and when a seed is jammed between the Applicator Needle Chuck and the Seed Cartridge, DO NOT force the
seed Magazine out of the Magazine receptor area of the Applicator. Undue pressure on the seeds may cause
the seeds to break or rupture. The following techniques can be attempted:

♦    Partially unscrew the head of the magazine (no more than one turn), thereby relieving the downward pres-
     sure on the seeds. Please note that the Magazine Head and the cartridge are NOT designed or intended to
     be taken apart. This is only done to relieve the spring pressure on the seeds. Carefully attempt to remove
     the Magazine from the Applicator. DO NOT USE FORCE; PREVENT SEEDS FROM RUPTURING!

♦    Flush the jammed seed out of the Applicator using a light pressure water flush. This must be done over a
     collection pan situated such that all seeds are collected and accounted for.

If the seeds cannot be removed safely, place the Applicator in quarantine. The Applicator must be surveyed (for
radiation) to determine if a broken seed has contaminated the Applicator.

If contaminated, the Applicator must remain in quarantine for a minimum of 10 half-lives for I-125 or Pd-103
seeds.

If clean, it is recommended that the Applicator be returned to the manufacturer for evaluation and repair/
adjustment.

Returning an Applicator for Service or Repair:

1: Call MRNI, Inc., Customer Service Tel. 914-667-3999 to obtain a “Return Authorization” number and a
   Certificate of Decontamination, Form 414-10.

2:   Mick Applicators (Instrument only) must be sterilized before sending to MRNI, Inc.
3: MRNI, Inc. will fax you form #414-10 to be completed by you (without the proof of a decontamination form,
   your Mick Applicator will be returned unserviced).

Upon MRNI’s Receipt of Mick Applicator:

The Mick Applicator will be analyzed to determine the extent of the repair. We will then call the Contact Person
to get authorization for repair and cost before we commence with any work.



                                                         16
                                                                             Useful Tips
                                                                                    Useful Tips

                               Useful Tips
                                       Preparations
      Prior to surgery it is imperative that the instrumentation is in proper operating condition
and that all components necessary are accounted for. The Mick sterilization cassette is con-
structed to store and simultaneously sterilize all components required for surgery. (Seeds
excluded.)
  “DO NOT AUTOCLAVE THE PRACTICE PHANTOM & DUMMY SEEDS” (see page 9)
            SEPARATE DUMMY SEEDS FROM RADIOACTIVE SEEDS!
                    DO NOT IMPLANT DUMMY SEEDS!

                                         CAUTION
              REMOVE PUSHWIRE ROD ASSEMBLY AND DISPOSABLE NEEDLES
              FROM THE MICK APPLICATOR PRIOR TO STEAM STERILIZATION.
            Disposable needles are manufactured with “plastic” sleeves and hubs.
           When inserted into the needle chuck and steam sterilization takes place,
           the needle sleeve will melt inside the needle receptor. Further use of the
           applicator is therefore no longer possible unless factory repaired.

                                 Seed Accountability
It is imperative to label the “radioactive” seed carriers (Seed Sterilizer) properly. Attach
an appropriate “CAUTION-RADIOACTIVE” label which clearly states the name of the pa-
        tient, date, type of isotope, number of seeds and “ACTIVITY” of the seeds.
                             The label must be dated and signed!

                                  Post Surgery Check
      Check used needles, instrumentation, containers, drapes, floor and all other
          related items for residual seeds with an appropriate and calibrated
              radiation survey meter. Every seed must be accounted for.
         ALL SURGICAL PRODUCTS USED DURING THE SURGERY MUST BE
                                  ACCOUNTED FOR!

                             Ball-Tipped Protective Sheath
 When you receive your new Mick 200-TP Applicator you will find that the tip of the attached
protective sheath (cannula) is provided with a stainless steel ball. The protective sheath is not
a needle but serves to protect the stylet from getting damaged or bent when the instrument is
                                            not in use.

            Unless in use, or undergoing sterilization in the cassette, always protect the
    Mick 200-TP Applicator’s stylet by keeping the PROTECTIVE BALL-TIPPED SHEATH
                                  attached to the applicator.

                                              17
                                                                  Useful Tips Continued
                                                                    Useful Tips/Things to be Aware Of!



Loading V-BLOCK: Loading of Seeds into Cartridges using the V-Block!
In order to facilitate the seed loading process, a V-Block is provided. The V-Block is designed to place the
cartridge into a fixed and stable position. The Loading V-Block can be autoclaved. Additionally, up to 5
magazines can be stored in the V-block, however, this device provides adequate shielding for I-125 and Pd-
103 seeds, but it is not designed to provide shielding for Au-198 seeds.


Isotopes: The difference between Au-198, 1-125 and Pd-103 Seeds:
Rarely used but still in practice, Gold seeds are approximately half in length as I-125 or Pd-103 seeds. Gold
seeds are “gold colored” and compatible with cartridges specifically manufactured for Au-198 seeds; they are
color coded “GOLD”. I-125 and Pd-103 are difficult to differentiate as they are the same in color, length and
diameter. Please refer to seed manufacturers information for more detailed seed specifications.


       Caution: Seeds are fragile and may rupture when handled with excess force!
       It is imperative to handle radio-isotopes with utmost care. Never use force, especially so during the seed
       loading process. Pick up seeds gently, preferably with the Reverse-Action Tweezer as provided by Mick
       Radio-Nuclear Instruments, Inc.


HANDLING MICK MAGAZINES
Do not handle loaded magazine by the extended plunger.
Loaded magazines are NOT designed to be taken apart. The internal cartridge contains radio active seeds
under spring pressure and disassembling may cause the seeds to fall out.


Reverse Action Tweezer
Reverse Action Tweezers are provided with a groove at the tip. The groove is shaped in form and size of a
seed. When picking up seeds, the groove captures the seed which facilitates the loading of the cartridge. It is
important to keep the groove looking downward. Keep the three marks located on the handle of the Reverse
Action Tweezer on top. This is to indicate that the groove is facing downward.


       Loop Wire (Stainless Steel Wire provided in kit)
        A thin wire with a loop at the end is enclosed with the kit. This wire serves to check needles for residual
        seeds once removed from the implant. Simply push the wire through a needle to ascertain that no seed
        (s) are left within the needle. It is advisable to have an empty cartridge, a tweezer, a V-Block and a
radiation monitor at hand when checking for residual seeds.


Maintenance/Service:
Repair / service of Mick Applicators (see page 7).




                                                          18
                                               Return Authorization Number
    IN ORDER FOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. TO RECEIVE AND ACCEPT AN
                   INSTRUMENT FOR CLEANING, SERVICE OR REPAIR, A
               “CERTIFICATE OF DECONTAMINATION” (Form #414-10)
                 MUST BE FILLED OUT BY THE CUSTOMER TO RECEIVE A
                       “RETURN AUTHORIZATION NUMBER”.
  FAILURE TO FILL OUT THE “CERTIFICATE OF DECONTAMINATION” FORM PROPERLY AND
    PRIOR TO DELIVERY WILL RESULT IN THE DEVICE BEING RETURNED TO THE CUSTOMER
                           UNOPENED AT CUSTOMERS EXPENSE.



                                               Returning “HOT” Applicators

                  DO NOT SHIP “HOT” APPLICATORS
    RETURNING UNAUTHORIZED HOT OR CONTAMINATED APPLICATORS COULD RESULT IN
       LOSS OF YOUR APPLICATOR IN ADDITION TO THE COST OF THE REMOVAL AND
             DISPOSAL PROCESS BY ENVIRONMENTAL WASTE MANAGEMENT.

                 (New York State Department of Health, Radiological Health Unit)



                                                                                    Warranty

           SIX (6) MONTHS PARTS / LABOR FOR DEFECTIVE MERCHANDISE ONLY!
       THE WARRANTY DOES NOT COVER ANY INJURY, LOSS, OR DAMAGE CAUSED BY
           IMPROPER USE OR HANDLING OF THE PRODUCT OR ANY USE OF THE
               PRODUCT IN CONNECTION WITH ANOTHER MANUFACTURER’S
                         NEEDLES, MAGAZINES OR PRODUCTS.




                                                                                   Disclaimer

   MICK RADIO-NUCLEAR INSTRUMENTS, INC. VOIDS ALL LIABILITIES AND WARRANTIES WHEN
MICK 200-TP APPLICATORS ARE USED WITH DISPOSABLE OR REUSABLE NEEDLES OR DISPOSABLE
             CARTRIDGES OR COMPONENTS OTHER THAN THOSE AUTHORIZED BY
                        MICK RADIO-NUCLEAR INSTRUMENTS, INC.

   DATA PROVIDED HEREIN IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED
    FOR CLINICAL USE OF ANY NATURE. USE OF THIS DATA IN SUCH A MANNER IS THE SOLE
 RESPONSIBILITY OF THE USER, AND THE AUTHOR OR SUPPLIER OF THE INFORMATION MAKES
NO CLAIM OR INFERENCE AS TO ITS CLINICAL SUITABILITY AND /0R ACCURACY. THE AUTHOR AND
 OR DISTRIBUTOR OF THIS DOCUMENT ACCEPT NO RESPONSIBILITY FOR THE USE OF THE DATA
AND INFORMATION CONTAINED HEREIN. MICK RADIO-NUCLEAR INSTRUMENTS, INC. ASSUMES NO
           WARRANTY OR LIABILITY FOR USE OF THIS INFORMATION OR PRODUCT.




                                              19

				
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Description: Mick TP MANUAL Mar tweezer